JP6840892B2 - Proximal and distal detachment transport system - Google Patents

Description

The present invention relates to an apparatus for transporting an expandable stent. More specifically, the present invention relates to a device that selectively deploys a stent from the distal side to the proximal side or from the proximal side to the distal side.

Transport devices for expandable stents, such as stents used in endoscopic applications, generally include an outer sheath that retracts to allow the stent to be radially expandable at the target site. When the outer sheath is retracted proximally, the stent is exposed from the distal side to the proximal side, so that the distal end of the stent is first exposed and the stent expands distally to proximally. .. In this mode of deployment, the distal end of the stent can be placed at a specific site. However, the final position of the proximal end of the stent is unknown until the stent is fully dilated, especially if the stent is self-expanding. If you wish to place the proximal end of the stent in a specific position, when expanding the stent from distal to proximal, estimate where the proximal end will be when the stent expansion is complete. There is a need to. Such estimates may not have the desired accuracy required for proper placement of the stent. Therefore, there remains a continuing need for alternative transport devices that selectively expand the stent in either a distal-to-proximal or proximal-to-distal fashion.

The present invention provides designs, materials, and alternative applications for medical devices, including transport systems.
The first example includes a stent transfer system. The system comprises an elongated inner member extending between the distal tip and the proximal end and a stent surrounding the stent receiving portion of the elongated inner member, the stent being retracted. It has a morphology and an expanded morphology. The system is slidably placed over the inner member and has an outer sheath that extends between the distal and proximal ends and a stent sheath that surrounds the stent to hold it in contractile form. And a proximal connection that can detachably connect the distal end of the outer sheath to the proximal end of the stent sheath and drive the distal end of the outer sheath to selectively detach from the proximal end of the stent sheath. It is provided with a portion and a distal connecting portion capable of removably connecting the distal end of the stent sheath to the distal tip of the inner member and driving the stent sheath to be selectively detached from the distal tip. The proximal junction can be driven by rotating the inner member in the first direction with respect to the outer sheath, and the distal connector can drive the inner member in the first direction with respect to the outer sheath. Can be driven by rotating in the opposite second direction, at least the first dilation element is located at the distal tip or the distal end of the outer sheath and the first stent dilation element recedes radially. It has a morphology and a morphology that rises in the radial direction.

Alternatively or additionally to any one of the above embodiments, the distal tip comprises a proximally threaded element and the distal end of the outer sheath is distally threaded. With elements, the stent sheath has threaded cavities at the distal and proximal ends so that the threaded cavities accept threaded elements that extend proximally and distally. It is configured.

Alternatively or additionally to any one of the above embodiments, the threaded elements extending distally and proximally are tapered.
Alternatively or additionally to any one of the above embodiments, the distal and proximal threaded connections are completely detached with a rotation of 360 degrees or less.

Alternatively or additionally to any one of the above embodiments, the first stent dilating element is a threaded element extending proximally at the distal tip or far at the distal end of the outer sheath. The first stent expansion element comprises a first elongated member having a first end coupled to a threaded element extending in the direction of the position, the first stent expanding element having a second on the opposite side of the first end. Has a free end.

Alternatively or additionally to any one of the above embodiments, the stent transfer system further comprises a first spring that urges the first stent expansion element into the ascending mode.
Either alternatively or additionally to one of the above Examples, the first spring extends in the longitudinal hand axis through the threaded portion of the threaded element on which the first elongate member is secured Arranged in the first groove, the first elongated member is arranged inward of the first groove when the first stent dilating element is in the retracted form.

Alternatively or additionally to any one of the above embodiments, the stent transfer system was placed adjacent to the first end of the first elongated member from the proximal part of the outer sheath. It further comprises a first slider element extending to the distal end, the first slider element being configured to slide over a portion of the first elongated member and ascending the first stent expansion element. Move from the hour form to the retreat form.

Alternatively or additionally to any one of the above embodiments, the first stent dilation element is located at the distal tip and the system is located at the distal end of the outer sheath. Further provided with a stent expansion element.

Alternatively or additionally to any one of the above embodiments, the first stent dilation element comprises a proximally extending free end and the second stent dilating element has a distally extending free end. To be equipped.

Alternatively or additionally to any one of the above embodiments, the first stent dilation element is located at the distal tip and the system is located at the distal end of the outer sheath. Further comprising a stent dilation element, the second stent dilation element is located at the distal end of the outer sheath and at the opposite side of the first end and the first end secured to a threaded element extending distally. The second stent expansion element comprises a second elongated member with two free ends, the second stent dilating element has a radially retracted form and a radially raised form, and the second slider element is: Extending from the proximal portion of the outer sheath to the distal end located adjacent to the first end of the second elongated member, the second slider element is one of the second elongated members. Configured to slide over the portion, the second stent dilating element transitions from the ascending form to the retracting form.

Alternatively or additionally to any one of the above embodiments, the first and second sliders can be moved separately.
Alternatively or additionally to any one of the above embodiments, the stent disengages the proximal connection and moves both the distal tip and the stent sheath distally to the stent. This allows it to be deployed from the proximal side to the distal side.

Alternatively or additionally to any one of the above embodiments, the stent disengages the distal junction and moves both the stent sheath and the outer sheath proximal to the stent. Can be deployed from the distal side to the proximal side.

Another example is the method of selectively deploying the stent from the proximal side to the distal side or from the distal side to the proximal side, which comprises the step of advancing the stent transfer system to the target site. The stent transport system surrounds the elongated inner member extending between the distal tip and the proximal end and the stent receiving portion of the elongated inner member in contraction and expansion forms. A stent comprising a long outer sheath that is slidably placed on the inner member and extends between the distal and proximal ends, and a distal inner member that surrounds the stent. A stent sheath that is detachably connected to the tip and the distal end of the outer sheath, a first stent dilation element located at the distal tip, and a distal end of the outer sheath. The first stent expansion element and the second stent expansion element include a second stent expansion element and a second stent expansion element, and the first stent expansion element and the second stent expansion element have a retracted morphology and an ascending morphology. The extension element is urged to the ascending form. The method is to rotate the inner member in the first rotational direction with respect to the outer sheath in order to selectively detach the distal end of the stent sheath from the distal tip, and to expose the stent. Including the step of deploying the stent from the distal to the proximal direction by moving the stent sheath connected to the outer sheath in the proximal direction with respect to the stent, and moving the stent sheath from the distal tip to the proximal direction. By moving to, the first stent dilation element returns to its urged ascending form, anchoring the stent while the stent sheath is moved proximally from the stent. Alternatively, the method selectively detaches the distal end of the outer sheath from the proximal end of the stent sheath in the inner member in a second direction of rotation opposite to the first direction of rotation. Proximal to distal by rotating the sheath with respect to the outer sheath and moving the stent sheath attached to the distal tip to expose the stent in the distal direction with respect to the stent. By moving the stent sheath distally from the distal end of the outer sheath, including the step of deploying the stent in the direction, the second stent dilation element returns to its urged ascending form and the stent sheath. Fix the stent while it is moved distally from the stent.

Another example is an elongated inner member extending between the distal tip and the proximal end, and a contracted and expanded forms surrounding the stent receiving portion of the elongated inner member. A stent to be held, an outer sheath that is slidably arranged on the inner member and extends between the distal and proximal ends, and a stent sheath that surrounds the stent to hold it in contractile form. Be prepared. The system can be driven to detachably connect the distal end of the outer sheath to the proximal end of the stent sheath and selectively detach the distal end of the outer sheath from the proximal end of the stent sheath. A position connection and a distal connection that can be driven to detachably connect the distal end of the stent sheath to the distal tip of the inner member and selectively detach the stent sheath from the distal tip. Further prepare. The proximal connection is driven by rotating the inner member in the first direction with respect to the outer sheath, and the distal connection is driven by rotating the inner member in the first direction with respect to the outer sheath. Driven by rotating in the opposite second direction, the first stent dilation element is located at the distal tip and the second stent dilation element is located at the distal end of the outer sheath. The first stent expansion element and the second stent expansion element each have a radially retracted form and a radially elevated form, and the first stent expansion element is fixed to a distal tip. It comprises a first elongated member with one end and a second free end, and a second stent dilating element has a first end and a second end fixed to the distal end of the outer sheath. It comprises a second elongated member with a free end of the first stent expansion element and a second stent expansion element, respectively, urged in ascending morphology.

Alternatively or additionally to any one of the above embodiments, a stent delivery system includes a first extending from the distal tip through the threaded portion of the threaded element extending proximally to the long hand axis 1 A first spring arranged in the groove of the first elongated member, which is arranged below the first end portion of the first elongated member and urges the first elongated member to the ascending form. The spring and the first elongated member are located inward of the first groove when the first stent dilation element is in the retracted form and distal to the distal end of the outer sheath. through the threaded portion of the threaded element extending a second spring disposed in the second groove extending in the long hand axis direction, disposed under the first end of the second elongated member The second elongated member comprises a second spring that urges the second elongated member into the ascending form, and the second elongated member is the second when the second stent expansion element is in the retracted form. It is placed inside the groove of.

Alternatively or additionally to any one of the above embodiments, the stent transfer system was placed adjacent to the first end of the first elongated member from the proximal part of the outer sheath. A first slider that extends to the distal end and is configured to slide along a portion of the first elongated member, moving the first stent dilation element from the ascending form to the retracting form. Extending from the proximal part of the outer sheath to the distal end located adjacent to the first end of the second elongated member, along a portion of the second elongated member It comprises a second slider element that is configured to slide in and moves the second stent expansion element from the ascending form to the retracting form.

Alternatively or additionally to any one of the above embodiments, the first slider element and the second slider element can be moved individually.
Alternatively or additionally to any one of the above embodiments, the distal tip comprises a proximally extending threaded element and the distal end of the outer sheath is distally threaded. With elements, the stent sheath comprises cavities threaded at the distal and proximal ends, said threaded cavities accepting and near threaded elements extending proximally and distally. The threaded elements extending in the position and distal directions are tapered respectively.

The above outline of the embodiments is not intended to show each or all of the embodiments disclosed in the present invention. The following drawings and detailed description exemplify the above embodiment more concretely.

The drawings below are not necessarily to scale, and similar components of different drawings have the same reference numerals. The drawings show a plurality of embodiments described herein for the purpose of general illustration and are not intended to be limiting.

A side view showing a stent transport system according to an embodiment of the present disclosure, including an enlarged view of the distal portion. A perspective view showing the proximal end of a system showing an embodiment of a handle assembly. An enlarged exploded perspective view showing the handle assembly of FIG. FIG. 2 is a cross-sectional view showing a handle assembly taken along line 4-4 of FIG. Longitudinal section showing a handle assembly with an inner member proximal to it. Longitudinal section showing a handle assembly with an inner member distally. An enlarged perspective view showing another example of the handle assembly. A side sectional view showing a distal portion of a stent transport system according to another embodiment of the present disclosure. Top view showing a stent transfer system released from the distal side to the proximal side. Top view showing a stent transfer system released from the proximal side to the distal side. Top view showing the distal end of the outer shaft and the distal end of the distal tip of an exemplary stent transfer system. FIG. 6 is a cross-sectional view showing a proximal connection between the distal end of the outer shaft of an exemplary stent transfer system and the proximal end of the stent sheath. Side sectional view showing the device of FIG. 12 with a partially removed stent sheath and a partially dilated proximal end of the stent. A side view showing the distal portion of the stent transfer system with an enlarged side sectional view of the distal tip. Top view showing the inner member and the outer sheath of the stent transfer system.

Various modifications and alternatives are possible of the present invention, the special ones of which are shown in the drawings and described in detail for the purpose of exemplifying them. However, this is not intended to be limited to specific embodiments that illustrate the invention. On the contrary, it is intended to cover all modified forms, equivalent forms and alternative forms that fall within the gist and scope of the present invention.

For the terms defined below, these definitions shall apply unless different definitions are given in either the claims or the specification. Definitions of certain terms are given and apply below, unless different definitions are given either in the claims or in the present specification.

In the present specification, it is assumed that all numerical ranges, with or without explicit description, are modified by the term "about". The term "about" generally refers to a numerical range that one of ordinary skill in the art would consider to be equal to the values described (ie, having the same function or result). In many cases, the term "about" indicates that it contains multiple digits that are rounded to the nearest significant digit. The numerical range by the end point includes all numbers within that range (for example, 1 to 5 includes 1,1.5,2,2.75,3,3.80,4,5). ..

Suitable sizes, ranges and values for various components, elements and features are described, but those skilled in the art will cite the present application and obtain the desired dimensions, ranges and values from the explicit description. Can be understood to be able to derive.

As used in this specification and the accompanying claims, the singular forms of "a", "an", and "the" clearly state the opposite. Unless not, it includes multiple objects as well as the singular. As used herein and in the appended claims, the term "or (or)" is used to include "and / or (and / or)" regardless of express description.

In the present specification, the descriptions such as "one embodiment", "one embodiment", "some embodiments", "some embodiments", "another embodiment", "another embodiment" and the like are referred to. It is shown that the embodiments or embodiments described may comprise one or more specific elements, structures, or properties. However, such description does not necessarily mean that all embodiments or examples have specific elements, structures, or features. In addition, when a specific element, structure, or feature is described in association with one embodiment or one embodiment, such element, structure, or characteristic may or may not be explicitly described. However, it can be used in the context of another embodiment or embodiment unless the opposite is explicitly stated.

The following detailed description should be read with reference to the drawings. Similar elements in different drawings have the same numbering. The detailed description and the drawings, which are not necessarily in scale, show exemplary embodiments and are not intended to limit the scope of the invention. The embodiments shown in the figure are merely examples. The selected elements of the embodiment shown in any figure can be incorporated into another embodiment unless the opposite is explicitly stated.

Figure 1 shows a stent delivery apparatus 100, the apparatus 100 includes an outer sheath 110, a stent sheath 105 extends slidably through the inside of the stent sheath 105 and the outer sheath 110 to the long hand axis Includes the inner member 120. The inner member 120 comprises a distal tip 122 fixed to the distal end. The outer sheath 110 covers most of the device 100 except for a portion of the distal end, including the stent sheath 105 and the distal tip 122. The outer sheath 110 is characterized by being a flexible tube comprising one or more lumens 114 extending inwardly. The outer sheath 110 and the proximal end of the inner member 120 are fixed or connected to the components of the handle assembly 150.

The inner member 120 is a flexible tube that extends through the inside of the lumen 114 of the outer sheath 110 and the inside of the hollow tubular stent sheath 105. Lumens 114, or one or more additional lumens, such as pull wires (not shown) to assist in navigating the transfer device 100 or driving one or more components of the transfer device 100. Guide elements can be placed. The device 100 is formed and configured with dimensions for use in a variety of medical applications, including, but not limited to, vascular applications or uses in the gastrointestinal tract such as biliary, esophageal, or colonic applications.

The proximal end of the inner member 120 is fixed or connected to the handle 130 of the handle assembly 150. The inner member 120 comprises a tubular portion extending between the proximal knob 152 and the distal tip 122, which penetrates the inside of the lumen 114 of the outer sheath 110 and the inside of the stent sheath 105. And extend. The inner member 120 includes at least one lumen 124, such as a guide wire lumen extending inward. For example, the lumen 124 extends along the overall length of the inner member 120 and the tip 122. In some cases, the stent transfer device 100 is moved over a guide wire (not shown), which is received in the lumen 124.

Stent sheath 105 is disposed along the length hand axis direction between the outer sheath 110 and the distal tip 122. For example, as shown in FIG. 1, the stent sheath 105 is detachably connected to the distal end 112 of the outer sheath 110 at the proximal connection 145 and at the distal end 140 at the distal connection 140. It is detachably connected to the proximal end 123 of 122. As an example of a detachable connection between the stent sheath 105, the outer sheath 110, and the distal tip portion 122, the screwing method can be mentioned. The connecting portions are threaded in opposite directions so that the proximal connecting portion 145 and the distal connecting portion 140 can be detached separately and independently. For example, the distal connection 140 is a right-hand thread 128 and the proximal connection 145 is a left-hand thread 118. With such a configuration, the distal connection 140 uses a handle to rotate the inner member 120 (and the distal tip 122) to the right with respect to the outer sheath 110 and the stent sheath 105, i.e. clockwise. Be separated by that. The proximal connection 145 is disengaged by rotating the outer sheath 110 clockwise with respect to the inner member handle 130, the stent sheath 105, the inner member 120, and the distal tip 122. The outer sheath 110 can be gripped directly at the proximal end, and the inner member 120 can be rotated by gripping and rotating the knob 152 or handle 130. Alternatively, the distal connection 140 may have a left-hand thread 128 and the proximal connection may have a right-hand thread 118. In such a configuration, the relative directions of rotation between the components are reversed. By reversing the threading of the distal connecting portion 145 and the proximal connecting portion 140, only one end of the stent sheath 105 (only one of the connecting portions) can be removed at a time. It can be deployed either (distal to proximal) or proximal to first (proximal to distal). In other words, the stent sheath 105 remains coupled to either the inner member 120 (via the distal tip 122) or the outer sheath 110, depending on the connecting portion to be separated.

In some examples, the handle assembly 150 includes a knob 152 located at the proximal end of the inner member 120, as shown in FIG. When the knob 152 is rotated, the inner member 120 rotates with respect to the outer sheath 110. As shown in FIG. 3 and described below, this rotation is provided by a slot 115 extending circumferentially through the outer sheath 110.

FIG. 3 shows the elements according to the example of the handle assembly 150. The elements include a connector 154 arranged inward of the outer sheath 110 and a handle 130 arranged along the outer circumference of the outer sheath 110. The handle 130 includes an inwardly extending pin 132 (see FIG. 4). The pin 132 extends through the slot 115 of the outer sheath 110 and the opening 156 of the wall of the connector 154 and is fixed to the inner member 120. The inner member 120, the connecting body 154, and the handle 130 can move in both the circumferential direction and the axial direction. The device user may rotate the inner member 120 with respect to the outer sheath 110 by rotating either the handle 130 or the knob 152 at the proximal end of the inner member 120. When the handle 130 is rotated, the pin 132 moves along the slot 115. The slot 115 is connected to and communicates with the elongated channel 111. The inner member 120 is axially slidable in the outer sheath 110 by moving either the handle 130 or the knob 152. The pin 132 moves along the elongated channel 111 as the handle 130 moves axially with respect to the outer sheath 110.

The connecting body 154 includes a plurality of finger-shaped protrusions 158 extending outward from the outer surface. In some examples, as shown in FIGS. 3 and 4, the protrusions 158 arranged on the outer peripheral surface of the first half of the outer circumference of the coupling 154 are curved in the first direction and the second half of the outer circumference. The protrusion 158 arranged on the outer peripheral surface of the is curved in a second direction opposite to the first direction. The connector 154 includes at least one set of opposing protrusions 158. In the example shown in FIG. 3, the connecting portion 154 includes a projection 158 which faces the two sets that are spaced along the length hand axis of the connector 154. The protrusion 158 slides along the inner peripheral surface of the outer sheath 110 when the connecting body 154 is rotated with respect to the outer sheath 110. The protrusion 158 holds the radial position of the inner member 120 and the connecting body 154 inside the outer sheath 110, while the connecting body 154 and the fixed inner member 120 are attached to the outer sheath 110. Make it rotatable.

As shown in FIGS. 4 and 5, the protrusion 158 is a bump 113 protruding from the inner peripheral surface of the outer sheath 110 and is sized to fit between two rings of the spaced bumps 113. To. As shown in FIG. 4, the bump 113 extends circumferentially along the inner surface of the outer sheath 110. The bumps 113 are spaced apart from each other in the circumferential direction by a distance sufficient for the protrusions 158 to pass between the adjacent bumps 113 when the coupling 154 is rotated to dispose the protrusions 158 between the bumps 113. The inner member 120, which is arranged and fixed to the connecting body 154 as shown by the difference in FIGS. 5 and 6, is moved in the distal direction. In some examples, marks 134 such as points, circles, and arrows are formed on the outer surface of the handle 130, and the marks are rotational positions that advance the handle 130 and the fixed inner member 120 in the distal direction. Is shown. The marked position is the position where the protrusion 158 of the coupling 154 is placed between the adjacent bumps 113. Different marks 136 are provided to indicate the starting point of the 360 degree rotation.

FIG. 5 shows a connector 154 and a handle 130 fixed to the inner member 120 in the most proximal position, with the protrusion 158 between the circumferential rings of the bumps 113 and axially into the bumps 113. Indicates that they are placed adjacent to each other. At this position, the handle 130, the connecting body 154, and the inner member 120 are rotatable with respect to the outer sheath 110, but because the protrusion 158 is arranged axially adjacent to the bump 113. , The handle 130, the connecting body 154, and the inner member 120 are prevented from moving in the axial direction with respect to the outer sheath 110. When the handle 130 is rotated to a position where the protrusion 158 is located between the bumps 113 adjacent in the circumferential direction, the handle 130 is then moved distally to the position shown in FIG.

FIG. 7 shows an alternative handle member. Channel 1111 along the inner member 1120 is disposed on the long hand direction, the outer sheath 1110 is provided with only slots 1115 extending in the circumferential direction. The handle assembly includes a handle 1130 with a pin (not shown) extending through a slot 1115 in the outer sheath 1110 and an opening 1156 of the connector 1154. Pin slides along the channels 1111 of the long hand axis of the inner member 1120 to permit axial movement of the inner member 1120 relative to the outer sheath 1110. The outer sheath 1110 comprises a proximal knob 1152 and the connector 1154 includes a protrusion 1158 that slides along the inner surface of the outer sheath 1110. The rotational movement of the inner member 1120 with respect to the outer sheath 1110 is formed by the pin coupled to the handle 1130 moving through the slot 1115. In this embodiment, the handle 1130 and the connector 1154 rotate, but do not move axially with respect to the outer sheath 1110. Axial movement is formed by moving the inner member 1120 so that the pin coupled to the handle 1130 slides along the channel 1111.

The threaded proximal end 123 of the distal tip 122 and the threaded distal end 112 of the outer sheath 110 are made substantially cylindrical as shown in FIG. Alternatively, the threaded proximal end 2123 of the distal tip 2122 of the inner member 2120 and the threaded distal end 2112 of the outer sheath 2110 are of the stent sheath 2105 as shown in FIG. Corresponds to the threaded end 2103 that tapers each end, both of which are tapered. The threaded proximal end 2123 of the distal tip 2122 and the threaded distal end 2112 of the outer sheath 2110 are illustrated as male threads (outer threads) and taper the stent sheath 2105. Engages with the female threaded portion (inner thread) of the screw-type end 2103. However, in another embodiment, the male threaded portion and the female threaded portion of one or both of the connecting portions may be reversed if desired. The tapered threaded end allows for rapid attachment / detachment between the threaded distal tip 2112 or outer sheath 2110 and the stent sheath 2105 at the connection. The number of threads may be reduced to allow for quick disengagement. For example, by making a tapered screw or reducing the number of threads, the screw type connection of the inner member 2120 or the outer sheath 2110 is completely engaged in one rotation (360 degrees) or less. Alternatively, it is possible to form a device that can be detached. In some embodiments, less than three-quarters (270 degrees) of one revolution, less than one-half (180 degrees) of one revolution, less than one-quarter (90 degrees) of one revolution, or less. The screw connection can be fully engaged or disengaged by rotation.

The inner member 120 comprises at least one stent receiving portion 126 located proximal to the distal tip 122 along the distal portion of the inner member 120. Since the stent 200 is arranged on the inner member 120 at the stent receiving portion 126 and surrounds the inner member 120, the inner member 120 extends through the stent 200, and the stent sheath 105 is a stent. Surround 200. The stent 200 is a self-expanding stent and is configured to automatically expand from a contractile form to an expandable form when the stent sheath 105 is removed from the stent. The stent 200 can be made of a metal alloy such as Nitinol®, spring steel, elastic polymers, or other materials well known in the art for making self-expandable stents. The stent sheath 105 holds the self-expandable stent 200 in the contracted diameter transport mode in the stent receiving portion 126 until the stent sheath 105 is moved to expose the stent 200. In another embodiment, the stent 200 can be manually expanded.

The stent 200 may have one or more markers (not shown) such as radiation opaque markers located at the distal end 210, the proximal end 220, or both. If the markers are present at both the proximal and distal ends 220,210 of the stent 200, the markers may be the same or different. In addition, alignment markers (not shown) may be placed on the outer sheath 110 or inner member 120 to indicate the relative rotational or torque directions between the elements. The alignment markers are radiation opaque and may be placed at any site along the length of the device as desired.

When either the distal connection 140 or the proximal connection 145 is disconnected (eg, unscrewed, unscrewed), the stent 200 attaches the distal tip 122 to the outer sheath 110. by moving in the direction away the long hand axis directions, exposed from the stent sheath 105, or be expanded. Movement of the long hand axis direction, or advance the inner member 120 in a distal direction and held stationary outward sheath 110, and held stationary with the inner member 120 in the proximal direction This can be achieved by retracting the outer sheath 110.

The stent 200 retracts the outer sheath 110 in the proximal direction as shown in FIG. 9 after the distal tip 122 is detached from the stent sheath 105 at the distal connection 140 (eg, unscrewed, unscrewed). (Along the stent sheath 105) to deploy distal to proximal. Alternatively, the stent 200 can be exposed from the distal end of the stent sheath 105 by advancing the inner member 120 distally. The handle 130 is rotated clockwise to disengage the distal connection 140 (eg, unscrew, unscrew) by rotating the distal tip 122 clockwise, as indicated by arrow 135. .. When the distal tip 122 is disengaged from the distal end 107 of the stent sheath 105, the outer sheath 110 and the stent sheath 105 are retracted proximally, holding the handle 130 immobile. .. The handle 130 slides along the elongated channel 111 up to position 130'. When the stent sheath 105 is moved proximally from the distal tip 122, the distal end 210 of the stent 200 is first exposed and the stent 200 expands distally to proximally. When the stent 200 is fully exposed and fully expanded, the inner member 120 and the distal tip 122 are retracted proximally through the expanded stent 200 and connected to the stent sheath 105 (eg, a screw). (Stop or screw), the device 100 places the stent 200 in the body and is removed from the patient's body.

The handle 130 can rotate with respect to the outer sheath in order to give rotational movement to the inner member 120 and the distal tip 122. The inner member 120 is advanced into the long hand direction relative to the outer sheath 110 by at outer sheath 110 and handle assembly 150. along the elongate channel 111 to move the handle 130 is retracted. A part of the handle 130 extends through the elongated channel 111 and is fixed to the inner member 120. The length of the elongated channel 111 is a position where the distal tip 122 is separated from the distal end 107 of the stent sheath 105, handle 130 to a distance longer than the length of the stent 200, the long hand axis Sufficient to move.

In the stent 200, the outer sheath 110 is detached from the stent sheath 105 at the proximal connection portion 145 (for example, unscrewed or unscrewed), and the inner member 120 is attached to the outer sheath 110 as shown in FIG. By advancing in the distal direction, it can be deployed from the proximal side to the distal side. Alternatively, the stent 200 can be exposed from the proximal end of the stent sheath 105 by retracting the outer sheath 110 in the proximal direction. The handle 130 rotates counterclockwise to rotate the stent sheath 105 counterclockwise, as indicated by arrow 137, to disconnect the proximal connection 145 (eg, unscrew or unscrew). It is rotated. When the outer sheath 110 is disengaged from the proximal end 109 of the stent sheath 105, the stent sheath 105 connected to the inner member 120 is distant by moving the handle 130 along the elongated channel 111. It is moved in the position direction, and the outer sheath 110 can be held in a stationary state. Alternatively, the outer sheath 110 is moved proximally. When the stent sheath 105 is moved distally from the outer sheath 110, the proximal end 220 of the stent 200 is first exposed and the stent 200 expands proximal to distal. When the stent 200 is fully exposed and fully expanded, the inner member 120, the distal tip 122 and the stent sheath 105 are retracted proximally through the expanded stent 200 and the outer sheath Engaged with 100 (eg, screwed or screwed), device 100 places a stent 200 in the body and is removed from the patient's body.

The stent 200 may be self-expanding or may be manually dilated with the device, such as a balloon (not shown). In some cases, a stent dilator 160a (shown in FIG. 14) is provided at the proximal end 123 of the distal tip 122, or a stent dilator 160b (shown in FIG. 12) is distant from the outer sheath 110. It is provided at the position end 112. FIG. 11 shows the elements of the stent dilator 160a / 160b. One end of the stent dilator 160a / 160b is in a groove 166a formed in the threaded distal end 112 of the channel or outer sheath 110 or in a groove 166b formed in the proximal end 123 of the distal tip 122. It may include a fixed elongated member. The second free end of the stent dilator 160a / 160b may comprise an dilated tip 162a / 162b used to adjust the position of the stent 200 during dilation. A spring 164b is arranged under the stent expander 160b in the groove 166b, and as shown in FIG. 13, the stent expander 160b is urged to an elevated position and a radial outer position. In another embodiment, the stent dilator 160b is made of an elastic material and urges the stent dilator 160b in an elevated position and radially outward position. 12 and 13 show the driving of the stent dilator 160b fixed to the distal end 112 of the outer sheath 110. Note that a stent dilator 160a anchored to the proximal end 123 of the distal tip 122 can be configured as well. When the stent sheath 105 is placed over the stent 200 as shown in FIG. 12, the stent sheath 105 pushes the stent dilator 160b downward into the groove 166b to compress the spring 164b, so that the stent dilator 160b Does not interfere with the threaded connection between the stent sheath 105 and the distal end 112 of the outer sheath 110. When the stent sheath 105 is advanced distally from the stent 200, the spring 164b stretches, the stent dilator 160b returns to its urged form, and the tip 162b is the proximal end of the stent 200. It may contact the inner surface of the portion and exert a radial outward force on the stent 200 to help the stent 200 begin to expand from the proximal direction, as shown in FIG. In another example, the elasticity of the stent dilator 160b restores the stent dilator 160b to its elevated form when unrestrained by the stent sheath 105. The stent dilator 160b can assist in the expansion of the stent 200, whether the stent 200 is self-expanding or manually expanded. Furthermore, the tip 162b of the stent dilator 160b can also be used to move the fully dilated stent 200 if it is desired to adjust the final position of the stent 200. In some instances, the distal end portion 162b of the stent dilator 160b, when moved to the long hand direction relative to the stent 200 to the stent sheath 105 to facilitate deployment of the stent 200 from stent sheath 105, Can contact the inner surface of the stent 200.

When the stent 200 is fully expanded, the stent expander 160b must be returned to its contracted form within the groove 166b. For a stent dilator 160b anchored to the distal end 112 of the outer sheath 110, this is by moving the outer sheath slider 170 distally over the stent dilator 160b (eg, of the stent dilator 160b). Along the radial outer surface), such movement can push the stent dilator 160b radially inwardly downward into the groove 166b. In FIG. 13, the outer sheath slider 170 is in the retracted position and the distal end of the outer sheath slider 170 is located immediately proximal to the stent dilator 160b. A handle 174 or other drive that extends through the outer sheath 110 is connected to the proximal end of the outer sheath slider 170 and distally drives the outer sheath slider 170 along the stent dilator 160b. It is configured to move forward in the distal direction for movement. The outer sheath slider 170 is a substantially flat and thin element having sufficient hardness to push the stent dilator 160b downward into the groove 166b. The outer sheath slider 170 may move within the lumen of the outer sheath 110. Channels 176 penetrating the walls of the outer sheath 110 and the handle assembly 150 allow the handle 174 to move in the anteroposterior direction to drive the outer sheath slider 170.

FIG. 14 shows a stent dilator 160a anchored to the proximal end 123 of the distal tip 122. The inner member 120 is shown distally away from the stent sheath 105. The stent 200 has been removed for clarity. Being at the distal end 112 of the outer sheath 110, the stent dilator 160a, along with the spring 164a under the stent dilator 160a, is a groove 166a formed in the threaded proximal end 123 of the channel or distal tip 122. Can be fixed at one end of it. The spring 164a may urge the stent dilator 160a to an elevated position, i.e., a radially outward position, as shown in FIG. In another embodiment, the stent dilator 160a is made of elastic material and the stent dilator 160a is urged to an elevated position, i.e., a radial outward position. The expansion tip 162a is coupled or installed at the free end of the stent dilator 160a. As shown in the enlarged cross-sectional view of the distal tip 122 in FIG. 14, the inner member slider 180 is arranged at the distal tip 122. The inner member slider 180 is fixed to a slider extension portion 182 arranged in the second lumen 125 of the inner member 120 and adjacent to the guide wire lumen 124. Alternatively, the slider extension 182 is located within the guide wire lumen 124. The proximal end of the slider extension 182 is secured to a handle 184 (shown in FIG. 15) or another drive that extends through the outer sheath 110 or channel 186 of the handle assembly 150. When the handle 184 is in the most distal position, the inner member slider 180 is distal to the stent dilator 160a as shown in FIG. 14, and the stent dilator 160a takes an ascending form. When the handle 184 is moved proximally, the inner member slider 180 is moved proximally over the stent dilator 160a (eg, along the outer surface in the radial direction of the stent dilator 160a) and the stent. Push the dilator 160a downward into the groove 166a. Similar to the outer sheath slider 170 on the outer sheath 110, the inner member slider 180 and the slider extension 182 of the distal tip 122 are located at the proximal end of the distal tip 122 downward with the stent dilator 160a. A nearly flat and thin element that is hard enough to be pushed into the groove 166a of 123.

As shown in FIG. 9, while the stent 200 was expanded from the distal side, when the stent 105 was retracted proximally from the stent 200, the spring 164a was extended and the stent expander 160a was urged. Returning to position, the tip 162a contacts the inner surface of the distal end region of the stent 200 and exerts a radial outward force on the stent 200 to support the stent 200 expanding from the distal direction. In another example, the elasticity of the stent dilator 160a causes the stent dilator 160a to return towards the ascending position when unconstrained by the stent sheath 105. The stent dilator 160a can assist in expanding the stent 200, whether the stent 200 is self-expanding or manually expanded. Further, the tip 162a of the stent dilator 160a can also be used to move the fully dilated stent 200 if it is desired to adjust the final position of the stent 200.

As shown in FIG. 9, when the handle 174 connected to the outer sheath slider 170 is placed near the distal end of channel 176, the outer sheath slider 170 covers the stent dilator 160b in the distal direction. And by pushing the stent dilator 160b into the groove 166b, the stent sheath 105 can be disengaged from the proximal end of the stent 200. A handle 184 connected to the inner member slider 180 was placed near the distal end of channel 186, indicating that the inner member slider 180 was retracted distally to the stent dilator 160a. As shown in FIG. 14, the stent dilator 160a can be positioned in an elevated position. The stent dilator 160a is in a position to assist the stent 200, which dilates from the distal to the proximal direction. When the stent 200 is fully expanded, the handle 184 is moved proximally along channel 186 to move the inner member slider 180 proximally to move the stent expander 160a into the groove 166a. Push. When the stent dilator 160a is in the pushed position, the distal tip 122 penetrates through the dilated stent 200 and retracts proximally. The distal tip 122 is then connected to the distal end of the stent sheath 105 (eg, tightening or screwing) and the entire device is retracted.

While the stent 200 expands from the proximal to the distal direction, as shown in FIG. 10, the stent sheath 105 connected to the distal tip 122 is advanced distally from the outer sheath 110. , The spring 164a extends to return the stent dilator 160b to its urged ascending form, with the distal tip 162b contacting the inner surface of the proximal end region of the stent 200 and radially out of the stent 200. It exerts a force on the side to help the stent 200 expand from the proximal side. In another example, the elasticity of the stent dilator 160b causes the stent dilator 160b to return to its ascending form when unrestrained by the stent sheath 105. The stent dilator 160b assists in the expansion of the stent 200, whether the stent 200 is self-expanding or manually expanded. In addition, the tip 162b of the stent dilator 160b can also be used to move the fully dilated stent 200 if adjustment of the final position of the stent 200 is desired.

As shown in FIG. 10, when the handle 174 connected to the outer sheath slider 170 is placed near the proximal end of channel 176, the outer sheath slider 170 is retracted proximal to the stent dilator 160b. , The stent dilator 160b can take the ascending form as shown in FIG. The stent dilator 160b is in a position to assist the stent 200 in expanding from the proximal to the distal direction. A handle 184 connected to the inner member slider 180 is also placed near the proximal end of channel 186, and when the inner member slider 180 is placed proximally over the stent dilator 160a, the stent dilator 160a Is pushed into the groove 166a to allow the stent sheath 105 to disengage from the distal end of the stent 200.

When the stent 200 is fully expanded, the handle 174 is moved distally along the channel 176, the outer sheath slider 170 is moved distally, and the stent dilator 160b is moved downward in the groove 166b. Push in. When the stent dilator 160b is in the depressed position, the stent sheath 105 coupled to the distal tip 122 is retracted through the dilated stent 200. The distal tip 122 is then engaged (eg, indicating or screwing) the distal end of the stent sheath 105 to remove the entire device.

FIG. 15 is a top view showing the outer sheath 110 and the inner member 120 with the stent sheath 105 and the stent 200 removed for clarity. Both the outer sheath slider 170 and the inner member slider 180 are extended over each stent dilator 160a / 160b to push the stent dilator 160b / 160a into the groove 166b / 166a. This is indicated by the position of the handles 174,184. When the handle 174 connected to the outer sheath slider 170 is placed near the distal end of channel 176, the outer sheath slider 170 is placed over the stent dilator 160b at the distal end 112 of the outer sheath 110. Cover and extend distally. The handle 184 is connected to the inner member slider extension 182 and is near the proximal end of channel 186, the inner member slider 180 of the stent extension 160a on the proximal end 123 of the distal tip 122. It covers the top and indicates that it extends in the proximal direction. The device, along with the inwardly mounted stent 200, is advanced to a target site within the patient's body in such a configuration. In another example, the device, along with the inwardly mounted stent 200, is advanced to a target site within the patient's body, where the stent dilators 160a, 160b face each other so as to push the inner surface of the stent 200 radially outward. Equipped with a handle. When the device is at the desired site, the device user determines whether to deploy the stent 200 proximal to distal or distal to proximal, and then deploys the stent 200. For ease of use, one of the handles 174 and 184 is driven.

The materials that can be used for the various components and various tubular members of the transfer device 100 described herein include those that generally correspond to medical devices. For the sake of brevity, the following description will be made with respect to the outer sheath 110, the inner member 120 and the other components of the device 100. However, this is not intended to limit the devices or methods disclosed herein, and the description is applicable to other similar devices, components of the devices disclosed herein, or devices. ..

The various components of the equipment / systems disclosed herein include metals, metal alloys, polymers (some of which are described below), metal-polymer composites, ceramics, combinations thereof, and the like. Alternatively, another suitable material or the like is included. Examples of suitable metals and metal alloys are stainless steels such as 304V, 304L, 316LV stainless steels; mild steels; nickel-titanium alloys such as linear elastic and superelastic nitinol; other nickel alloys such as nickel-chromium-molybdenum alloys. (UNS such as INCONEL (registered trademark) 625: N06625, UNS such as HASTELLOY (registered trademark) C-22 (registered trademark): N06022, UNS such as HASTELLOY (registered trademark) C276 (registered trademark): N10276, and other HASTELLOY (Registered Trademarks) Alloys), Nickel-Copper Alloys (UNS: N04400 such as MONEL® 400, NICKELVAC® 400, NICORROS® 400), Nickel-Cobalt-Chrome-Molybdenum Alloys (MP35- UNS such as N (registered trademark): R30035), nickel-molybdenum alloy (UNS: N10665 such as HASTELLOY (registered trademark) ALLOY B2 (registered trademark)), other nickel-chromium alloys, other nickel-molybdenum alloys, etc. Nickel-Cobalt Alloys, Other Nickel-Iron Alloys, Other Nickel-Copper Alloys, Other Nickel-Tungsten or Tungsten Alloys; Other Cobalt-Chrome Alloys; Cobalt-Chrome-Molybdenum Alloys (ELGILOY® PHYNOX) UNS: R30003) such as (Registered Trademarks); Platinum reinforced stainless steel; Titanium; combinations thereof; etc .; or any suitable material can be mentioned.

Examples of suitable polymers include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), ethylene fluoride propylene (FEP), polyoxymethylene (POM, eg DELRIN® available from Dupont). ), Polyether block ester, polyurethane (eg Polymer85A), polypropylene (PP), polyvinyl chloride (PVC), polyale-ester (eg ARNITEL® available from DSM Engineering Plastics), ether or ester as a base. Polymers (eg, butylene / poly (alkylene ether) phthalates and other polyester elastomers such as HYTREL® available from Dupont), polyamides (DURETHAN® available from Bayer), or Elf Atchem. CRISTAMID®, Elastomer Polypropylene, Block Polypropylene / Ether, Polyether Blockamide (eg PEBA available under PEBAX®), Ethylene Vinyl Acetate Copolymer (EVA), Silicone, Polypropylene ( PE), Marlex high density polyethylene, Marlex low density polyethylene, linear low density polyethylene (eg REXELL®), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PE) PEN), polyether ether ketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulphide (PPS), polyphenylene oxide (PP), polyparaphenylene terephthalamide (eg KEVLAR®), Polysulfone, nylon, nylon-12 (eg GRIAMID® available from EMS American Griron), perfluoro (propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC), Poly (styrene-b-isobutylene-b-styrene) (eg SIBS and SIBS50A), polycarbonate, ionomers, biocompatible polymers, etc. Suitable materials or mixtures, combinations thereof, copolymers thereof, polymer / metal composites, etc. may be mentioned. In some embodiments, the sheath can contain a liquid crystal polymer (LCP). For example, the mixture can contain up to about 6% LCP.

In at least some embodiments, the transfer device 100 and some or all other components of the transfer system may be doped, formed or contained with a radiation opaque material. A radiation opaque material can be understood to be a substance capable of forming a relatively bright image on a fluorescent fluoroscopic screen or another imaging technique during a medical procedure. This relatively bright image assists the user of the transport device 100 in locating the device. Examples of radiation-impermeable substances include, but are not limited to, polymer materials to which gold, platinum, palladium, tantalum, tungsten alloys, radiation-impermeable fillers and the like are added. In addition, another radioactive opaque marker band or coil may be incorporated into the design of the transfer device 100 to achieve the same result.

It should be noted that this disclosure is merely exemplary in many respects. In detail, in particular the shape, dimensions, and structure of the process can be modified without departing from the scope of the invention. This may include using any element of one embodiment for another, within a suitable range. Needless to say, the scope of the present invention is defined by the wording expressed in the appended claims.

Claims (14)

An elongated inner member extending between the distal tip and the proximal end,
A stent that surrounds the stent receiving portion of the elongated inner member and has a contraction state and an expansion state.
An outer sheath that is slidably disposed on the inner member and extends between the distal and proximal ends.
In order to hold the stent in contracted form, a stent sheath surrounding the stent and
The distal end of the outer sheath can be detachably connected to the proximal end of the stent sheath and driven to selectively detach the distal end of the outer sheath from the proximal end of the stent sheath. Proximal connection and
A distance that can be driven to detachably connect the distal end of the stent sheath to the distal tip of the inner member and selectively detach the distal end of the stent sheath from the distal tip. With the position connection part,
The proximal connection is driven by rotating the inner member in a first direction with respect to the outer sheath, and the distal connection connects the inner member to the outer sheath. Driven by rotating in a second direction opposite to the first direction,
A first end fixed to at least one of the distal tip and the distal end of the outer sheath, and a second free end opposite to the first end. A first stent dilating element, which has a radial retreat form and a radial ascending form.
A stent transfer system. The distal tip comprises a screw element that extends proximally, the distal end of the outer sheath comprises a screw element that extends distally, and the stent sheath is distal and proximal. The first aspect of claim 1, wherein the threaded cavity comprises a threaded cavity at the end and accepts the threaded element extending in the proximal direction and the threaded element extending in the distal direction. Stent transfer system. The stent transfer system according to claim 2, wherein the screw-type element extending in the distal direction and the screw-type element extending in the proximal direction form a taper. The stent transfer system according to claim 3, wherein the distal screw connection and the proximal screw connection are each completely detached with a rotation of less than 360 degrees. Said first stent expansion element is threaded element extending in the proximal direction by the distal tip, or, the outer fixed to the threaded element extending in the distal direction at the distal end of the sheath the the first elongated member including having a first end, a stent delivery system according to any one of claims 2-4. The stent transfer system according to claim 5, further comprising a first spring that urges the first stent expansion element into the radial ascending mode. It said first spring, said first elongate member is disposed within the first groove extending in the long hand axis direction through the inside of the threaded portion of the threaded element to be fixed, the first elongate member, wherein when the first stent expansion element is in the radially retracted when the form is placed on the inner portion of the first groove, the stent delivery system of claim 6. The first slider element further comprises a first slider element extending from the proximal portion of the outer sheath to the distal end located adjacent to the first end of the first elongated member. The stent transport system according to claim 7, wherein the first stent expansion element shifts from the radial ascending form to the radial retracting form by sliding on a part of the first elongated member. .. Claims 1-8, wherein the first stent dilation element is located at the distal tip, and the stent transport system further comprises a second stent dilation element that is located at the distal end of the outer sheath. The stent transfer system according to any one of the above. The free end of the first stent extension element, extending Beauty proximally, second stent expansion element has a free end extending distally, the stent delivery system of claim 9. The first stent dilation element is located at the distal tip and the stent transfer system is
A second stent dilation element located at the distal end of the outer sheath, the first end fixed to a threaded element extending distally at the distal end of the outer sheath. The second stent expansion comprising a second elongated member comprising a second free end opposite to the first end and having a radial retracting form and a radially ascending form. Elements and
A second slider element extending from the proximal portion of the outer sheath to the distal end located adjacent to the first end of the second elongated member, the second elongated member. With the second slider element, which slides on a part of the member to move the second stent expansion element from the radial ascending form to the radial retracting form.
8. The stent transfer system according to claim 8. The stent transfer system according to claim 11, wherein the first slider element and the second slider element can be moved individually. The stent is moved from the proximal side to the distal side by disconnecting the proximal connecting portion and moving the distal tip portion and the stent sheath together in the distal direction with respect to the stent. The stent transfer system according to any one of claims 1 to 12, which is deployable. The stent is deployed from the distal side to the proximal side by disconnecting the distal connecting portion and moving the stent sheath and the outer sheath together in the proximal direction with respect to the stent. The stent transfer system according to any one of claims 1 to 13, which is possible.

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